Quality Assurance

Quality is at the heart of what we do

Our Quality Vision

The FUJFILM Diosynth Biotechnologies Quality Vision is to establish an effective pharmaceutical quality system which integrates regulatory compliance requirements with patient safety and Active Pharmaceutical Ingredients (API) quality requirements. This will be achieved by utilizing risk management and continuous improvement principles throughout the facilities and API lifecycles to foster innovation and promote ownership of quality and compliance by all employees.

Our regulatory history includes FDA (CBER & CDER), MHRA, EMA, Health Canada, ANVISA, and certification by JMHLW, among the many agencies that have inspected our sites.

Our Global Quality Group provides:

Quality Agreement followed by routine interactions with customer throughout the duration of a program

Regulatory support for IND/CTA submission, DMF and CMC

QC analysis and release of raw materials, environmental and water in-process/final, sample retention

The FDA Provided Guidance for Quality Agreements

This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (cGMP).

We support our customers through the application of good science, our knowledge of the clinical process and our quality driven approach. For inquiries on How We Can Help, contact FUJIFILM Diosynth by completing this form:

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